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NCT05933603 · ClinicalTrials.gov registry record · Phase 2
Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
A Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05933603 is a Phase 2 study of Obstructive Sleep Apnea and Down Syndrome that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 36 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05933603, a Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced. Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.
Conditions Studied
Interventions
- DRUG Atomoxetine and Oxybutynin (ato-oxy)
Study Locations (1)
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05933603
The ClinicalTrials.gov registry entry for NCT05933603 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (84% lower). The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Atomoxetine and Oxybutynin (ato-oxy) is the first listed.
NCT05933603 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT05933603 about?
NCT05933603 is a clinical study titled "Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome". This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 m...
What is the current status of trial NCT05933603?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2023-09-29. Estimated completion is 2025-12.
What conditions does trial NCT05933603 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Down Syndrome.
What interventions are being tested in trial NCT05933603?
The interventions under investigation include: Atomoxetine and Oxybutynin (ato-oxy) (DRUG).
Who is sponsoring clinical trial NCT05933603?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05933603 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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